Spiriva Respimat
(Tiotropium Bromide)

What Spiriva Respimat is and what it is used for

Spiriva Respimat helps people who have chronic obstructive pulmonary disease (COPD) or asthma to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Asthma is a long-term disease characterised by airway inflammation and narrowing of the airways. As COPD and asthma are long-term diseases you should use Spiriva Respimat every day and not only when you have breathing problems or other symptoms. When used to treat asthma you should use Spiriva Respimat in addition to so-called inhaled corticosteroids and long-acting ß2 agonists. Spiriva Respimat is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of Spiriva Respimat can also help you when you have on-going shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life. Daily use of Spiriva Respimat will also help to prevent any sudden, short-term worsening of your COPD symptoms which may last for several days. For correct dosing of Spiriva Respimat please see section 3. How to use Spiriva Respimat and the instructions for use provided on the other side of the leaflet

How to take Spiriva Respimat

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Spiriva Respimat is for inhalation use only. The recommended dose for patients 6 years and older is: Spiriva Respimat is effective for 24 hours so you will need to use Spiriva Respimat only ONCE A DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS. As COPD and asthma are long-term diseases use Spiriva Respimat every day and not only when you experience breathing problems. Do not use more than the recommended dose. Spiriva Respimat is not recommended for use in children below 6 years due to lack of data on safety and efficacy. Make sure that you know how to use your Spiriva Respimat inhaler properly. The instructions for use of the Spiriva Respimat inhaler are provided on the other side of this leaflet. If you use more Spiriva Respimat than you should If you use more Spiriva Respimat than two puffs in one day talk to your doctor immediately. You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, increased heart beat or blurred vision. If you forget to use Spiriva Respimat If you forget to take a dose (TWO PUFFS ONCE A DAY), take it as soon as you remember but do not take two doses at the same time or on the same day. Then take your next dose as usual. If you stop using Spiriva Respimat Before you stop using Spiriva Respimat, you should talk to your doctor or your pharmacist. If you stop using Spiriva Respimat the signs and symptoms of COPD and asthma may worsen. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Evaluation of the side effects is based on the following frequencies:

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Not known: frequency cannot be estimated from the available data The side effects described below have been experienced by people taking this medicine and they are listed according to frequency as either common, uncommon, rare or not known. Side effect Frequency COPD Frequency Asthma Dry mouth

Common

Uncommon Hoarseness (dysphonia)

Uncommon

Uncommon Cough

Uncommon

Uncommon Headache

Uncommon

Uncommon Inflammation of the throat (pharyngitis)

Uncommon

Uncommon Painful urination (dysuria)

Uncommon

Not known Dizziness

Uncommon

Uncommon Fungal infections of the oral cavity and throat (oropharyngeal candidiasis)

Uncommon

Uncommon Difficulties passing urine (urinary retention)

Uncommon

Not known Constipation

Uncommon

Rare Rash

Uncommon

Uncommon Itching (pruritus)

Uncommon

Rare Increase of the measured eye pressure

Rare

Not known Serious allergic reaction which causes swelling of the mouth and face or throat (angioneurotic oedema)

Rare

Rare Difficulty in sleeping (insomnia)

Rare

Uncommon Irregular heart beat (atrial fibrillation, supraventricular tachycardia)

Rare

Not known Feeling your heartbeat (palpitations)

Rare

Uncommon Nosebleed (epistaxis)

Rare

Rare Inflammation of the tongue (glossitis)

Rare

Not known Faster heart beat (tachycardia)

Rare

Not known Tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)

Rare

Uncommon Difficulties swallowing (dysphagia)

Rare

Not known Seeing halos around lights or coloured images in association with red eyes (glaucoma)

Rare

Not known Blurred vision

Rare

Not known Inflammation of the larynx (laryngitis)

Rare

Not known Dental caries

Rare

Not known Inflammation of the gums (gingivitis)

Rare

Rare Nettle rash (urticaria)

Rare

Rare Infections or ulcerations of the skin

Rare

Not known Dryness of the skin

Rare

Not known Infections of the urinary tract

Rare

Rare Heart burn (gastrooesophageal reflux disease)

Rare

Not known Hypersensitivity, including immediate reactions

Not known

Rare Inflammation of the mouth (stomatitis)

Not known

Rare Depletion of body water (dehydration)

Not known

Not known Inflammation in sinuses (sinusitis)

Not known

Not known Blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic)

Not known

Not known Feeling sick (nausea)

Not known

Not known Severe allergic reaction (anaphylactic reaction)

Not known

Not known Swelling of joint

Not known

Not known Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of the mouth and face or sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or dizziness) may occur individually or as part of severe allergic reaction (anaphylactic reaction) after administration of Spiriva Respimat. In addition, in common with all inhaled medicines, some patients may experience an unexpected tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (bronchospasm). If any of these occur, please consult your doctor immediately.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Earlsfort Terrace, IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

How to Store Spiriva Respimat

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the inhaler label. The expiry date refers to the last day of that month. Spiriva Respimat inhaler should be discarded at the latest 3 months after first use (see Instructions for Use overleaf). Do not freeze. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.